Abstract: A radiotherapy system, and preferably a brachytherapy system, for delivering radiation to tissue surrounding an interstitial space is provided. While the system can be used for a variety of purposes, the system is preferably used to treat spinal metastases. In general, the system includes a catheter member having a proximal end, a distal end, and an inner lumen extending therethrough, and a structural support adapted to fit within an interstitial space in load bearing portion of a patient's body and having an internal space for removably receiving the distal end of the catheter member. At least one anchoring element can be disposed proximate to the distal end of the catheter. The anchoring element is preferably adapted to fit within the internal space in the structural support so as to anchor the distal end of the catheter therein.

Abstract: An interstitial brachytherapy apparatus and methods for treating proliferative tissue disorders with radiation and a surface delivered treatment agent. The brachytherapy device includes an insertion member having proximal and distal portions and at least one lumen extending therethrough. An expandable surface member is mated to the distal portion of the insertion member and includes a treatment agent releasably mated thereon. When the brachytherapy device is positioned within a tissue cavity and the expandable surface member is expanded, at least a portion of the treatment agent is delivered to tissue surrounding the tissue cavity.

Abstract: A system for treating tissue surrounding a resected cavity that is subject to a proliferative tissue disorder is provided. The system includes a tissue fixation device including a catheter body member having a proximal end, a distal end, an inner lumen, and an expandable surface element disposed proximate to the distal end of the body member, the expandable surface element sized and configured to reproducibly position tissue surrounding a resected tissue cavity in a predetermined geometry upon expansion. After expansion of the expandable surface element within a resected tissue cavity, an external radiation device positioned outside the resected cavity delivers a dose of radiation to the tissue surrounding the expandable surface element.

Abstract: An interstitial brachytherapy apparatus and method for delivering and monitoring radioactive emissions delivered to tissue surrounding a resected tissue cavity. The brachytherapy device including a catheter body member having a proximal end, a distal end, and an outer spatial volume disposed proximate to the distal end of the body member. A radiation source is disposed in the outer spatial volume and a treatment feedback sensor is provided on the device. In use, the treatment feedback sensor can measure the radiation dose delivered from the radiation source.

Abstract: A brachytherapy device is provided for treating a target tissue through an external surface area of the target tissue. The device includes an insertion member having a proximal portion, a distal portion, and at least one lumen extending therethrough. A fluid retaining member is mated to the distal portion of the insertion member and has a first surface shaped to conform to a predetermined external surface area of a tissue to be treated, and a cavity formed therein in fluid communication with the at least one lumen in the insertion member. A plurality of anchor members can be distributed about a periphery of the first surface to anchor the first surface to an external surface area of a tissue to be treated.

Abstract: A brachytherapy system for treating metastases on and around a patient's spinous process is provided. The device generally includes a catheter member having a proximal portion, a distal portion, and at least one lumen extending therethrough. The distal portion of the catheter member includes first and second branch members that are adapted to be positioned on opposed sides of a patient's spinous process. The device further includes first and second elongate anchoring elements disposed on the first and second branch members, and optionally can include at least one centering mechanism disposed within each of the first and second anchoring elements.

Abstract: A spacing apparatus for use with radiation therapy devices, and in particular, for use with a brachytherapy device. The spacing apparatus is useful in that the instrument is effective to limit the amount of radiation that comes into contact with the sensitive tissue proximate to the extraction site, and thereby protect sensitive tissue from overheating or hotspots, and/or protect against radiation exposure outside of the patient's body which may affect healthcare providers or others who might come close to the patient. In particular, the spacing apparatus is effective to control the proximity of a brachytherapy device to the outer surface of the sensitive tissue proximate to a surgical extraction site.

Abstract: An infuser for transferring hazardous treatment fluids to and from a medical application includes a spill containing housing having a medical application connecting element and a syringe seat. The syringe seat of the infuser leads to a syringe connecting element that provides a fluid coupling between the syringe and a fluid passage leading to the medical application connecting element. The interior of the housing can be sealed against leaks, for example, by providing the housing in two portions with a gasket provided between the portions. A fluid tight coupling between the syringe and the interior of the housing may be created by integrally forming a septum with the gasket and coupling the syringe with the syringe connecting element through the septum. The infuser can also be provided with two syringe seats so that two different fluids can be transferred. In one embodiment, a second syringe connecting element is provided in fluid-tight communication with a second fluid passage.

Abstract: Drug delivery vehicles and catheter systems are disclosed for controlled release of therapeutic agents employing a permeable hydrogel membranes a reservoir for an inflation fluid carrying a therapeutic agent. The membrane devices of the present invention can be used in conjunction with a catheter or similar instrument having an elongated hollow body member and a lumen extending therethrough to permit fluid communication between a proximal infusion port and a permeable membrane disposed at the distal end of the catheter body. The membrane preferably comprises an expandable, hydrophilic polymer having a predetermined permeability with respect to an inflation fluid. One preferred hydrophilic polymer is a hydrogel capable of imbibing an aqueous solution to reach a state in which it comprises between 50% and 98% water by weight in equilibrium. In this state, the hydrogel membrane serves to control the rate of medicament delivery.

Abstract: An interstitial brachytherapy apparatus of the invention delivers radioactive emissions in an asymmetric fashion to target tissue surrounding a surgical extraction site. The apparatus includes an expandable outer surface element defining an apparatus spatial volume, a radiation source disposed within the apparatus volume, and a means for providing predetermined asymmetric isodose curves within the target tissue. In one configuration, asymmetric isodose curves are created in the target tissue by shaping or locating the radiation source so as to be asymmetrically placed with respect to a longitudinal axis of the apparatus. In other configurations, asymmetric radiopaque shielding is provided between the radiation source and the target tissue. A surgical procedure using the apparatus is also described.

Abstract: An interstitial brachytherapy apparatus for delivering radioactive emissions to an internal body location includes a catheter body member having a proximal end and distal end, an inner spatial volume disposed proximate to the distal end of the catheter body member, an outer spatial volume defined by an expandable surface element disposed proximate to the distal end of the body member in a surrounding relation to the inner spatial volume, and a radiation source disposed in the inner spatial volume.

Abstract: An infuser for transferring hazardous treatment fluids to and from a medical application includes a spill containing housing having a medical application connecting element and a syringe seat. The syringe seat of the infuser leads to a syringe connecting element that provides a fluid coupling between the syringe and a fluid passage leading to the medical application connecting element. The interior of the housing can be sealed against leaks, for example, by providing the housing in two portions with a gasket provided between the portions. A fluid tight coupling between the syringe and the interior of the housing may be created by integrally forming a septum with the gasket and coupling the syringe with the syringe connecting element through the septum. The infuser can also be provided with two syringe seats so that two different fluids can be transferred. In one embodiment, a second syringe connecting element is provided in fluid-tight communication with a second fluid passage.

Abstract: An infuser for transferring hazardous treatment fluids to and from a medical application includes a spill containing housing having a medical application connecting element and a syringe seat. The syringe seat of the infuser leads to a syringe connecting element that provides a fluid coupling between the syringe and a fluid passage leading to the medical application connecting element. The interior of the housing can be sealed against leaks, for example, by providing the housing in two portions with a gasket provided between the portions. A fluid tight coupling between the syringe and the interior of the housing may be created by integrally forming a septum with the gasket and coupling the syringe with the syringe connecting element through the septum. The infuser can also be provided with two syringe seats so that two different fluids can be transferred. In one embodiment, a second syringe connecting element is provided in fluid-tight communication with a second fluid passage.

Abstract: Drug delivery vehicles and catheter systems are disclosed for controlled release of therapeutic agents employing a permeable hydrogel membranes a reservoir for an inflation fluid carrying a therapeutic agent. The membrane devices of the present invention can be used in conjunction with a catheter or similar instrument having an elongated hollow body member and a lumen extending therethrough to permit fluid communication between a proximal infusion port and a permeable membrane disposed at the distal end of the catheter body. The membrane preferably comprises an expandable, hydrophilic polymer having a predetermined permeability with respect to an inflation fluid. One preferred hydrophilic polymer is a hydrogel capable of imbibing an aqueous solution to reach a state in which it comprises between 50% and 98% water by weight in equilibrium. In this state, the hydrogel membrane serves to control the rate of medicament delivery.

Abstract: A completely implantable apparatus is provided for treatment of tissue surrounding a cavity left by surgical removal of a brain tumor. The apparatus includes an inflatable balloon constructed for placement in the cavity. A subcutaneously implantable treatment fluid receptacle is provided for receiving a transdermal injection of a treatment fluid. A catheter connects the receptacle to the inflatable balloon. Various embodiments provide for simultaneous application of heat therapy and/or radiation therapy and/or chemotherapy to the remaining tissue surrounding the cavity from which the tumor was removed.

Abstract: A completely implantable apparatus is provided for treatment of tissue surrounding a cavity left by surgical removal of a brain tumor. The apparatus includes an inflatable balloon constructed for placement in the cavity. A subcutaneously implantable treatment fluid receptacle is provided for receiving a transdermal injection of a treatment fluid. A catheter connects the receptacle to the inflatable balloon. Various embodiments provide for simultaneous application of heat therapy and/or radiation therapy and/or chemotherapy to the remaining tissue surrounding the cavity from which the tumor was removed.

Abstract: Implantable devices for treatment of proliferative disorders are described. In one aspect, the invention provides an implantable apparatus for treating a proliferative disorder in a patient. The device comprises a treatment fluid receptacle for receiving a treatment fluid, an inflatable balloon having a balloon body, a catheter connected between the treatment fluid receptacle and the balloon and defining a fluid flow path therebetween, and a diffusion barrier disposed in the fluid flow path between the treatment fluid receptacle and the balloon. Methods for treating proliferative disorders with the devices are also disclosed.

Abstract: An instrument for use in brachytherapy comprises a concentric arrangement of inner and outer distensible, spherical chambers disposed near the proximal end of a catheter body where one of the chambers is made to contain a radioactive material with the other chamber containing a radiation absorptive material, the apparatus functioning to provide a more uniform absorbed dose profile in tissue surrounding a cavity created by the removal of a tumor. An alternative embodiment includes non-spherical inner and outer chambers whose respective walls are spaced equidistant over the entire surfaces thereof.